Quality Engineer — Supplier & Product Quality (Hybrid)

Electromed Inc.; New Prague (MN); Hybrid; USD 70,000 - 118,000; Full time

Benefits offered by this job

Discretionary time off

Employee bonus plan

Hybrid/remote work options

Maternity/paternity leave

Recognition program

Training opportunities

Educational assistance

Well-being on demand

Perks at Work

HSA contribution

401(k) match

Great culture

Job summary

Electromed Inc. in New Prague, MN, is seeking a Quality Engineer to support supplier quality, incoming quality, complaints, and product quality trend analysis. You will work with suppliers, Operations, Regulatory, Design Assurance, and Document Control to identify and resolve quality issues affecting materials and field performance.

The role is based in New Prague, MN with flexible hybrid work options. Responsibilities include MRB administration, CAPA involvement, data analysis, and support for

Qualifications

• Bachelor’s degree from an accredited college or university.
• 2+ years of hands-on quality experience in supplier quality, incoming quality, complaints, nonconformance, or related activities; medical device manufacturing preferred.
• Experience with ISO9001-based standards (ISO9001, ISO13485, AS9100, or IATF16949).
• ASQ certifications (CQE, CRE, CSQP, CQA, CQI, CSSGB, CSSBB, or similar) preferred.
• Knowledge of ISO14971, ISO13485:2016, and FDA 21 CFR 820 preferred.
• Knowledge of basic statistics used in QA (capability, control charts, dispersion, sampling, T-tests/ANOVA).
• Exceptional communication skills and ability to manage multiple priorities with timely follow-up.
• Ability to travel <10%.

Responsibilities

• Collaborate with suppliers to resolve root causes of nonconforming material.
• Administer MRB process for disposition of rejected material.
• Maintain supplier quality metrics and scorecards.
• Lead or participate in supplier re-evaluation and audits.
• Support supplier corrective actions and follow-up.
• Analyze incoming quality data to identify recurring issues and risks.
• Support complaint handling and related records during audits.

Skills

Quality Assurance

Supplier Quality

Root Cause Analysis

Communication Skills

Multitasking

Education

Bachelor’s degree in a related field

ASQ certification (CQE/CRE/CQA etc.)

Job description

Electromed Inc. in New Prague, MN, is seeking a Quality Engineer to support supplier quality, incoming quality, complaints, and product quality trend analysis. You will work with suppliers, Operations, Regulatory, Design Assurance, and Document Control to identify and resolve quality issues affecting materials and field performance.

The role is based in New Prague, MN with flexible hybrid work options. Responsibilities include MRB administration, CAPA involvement, data analysis, and support for